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An Ongoing Debate:Should Rx Drug Ads Be Curtailed?

March 8 — The debate over whether prescription drugs should be advertised directly to consumers is heating up again.

Pharmaceutical industry and other experts told Bloomberg BNA that direct-to-consumer (DTC)
advertising is helpful because it gives patients information and spurs conversations with health-care professionals, but a consumer group said this type of advertising drives up the costs of drugs and often is misleading. Meanwhile, a business professor told Bloomberg BNA that DTC drug advertising can actually lower health-care costs because it leads people to get treated for their diseases or conditions.

DTC drug advertising has come under attack in recent months on Capitol Hill, in the presidential primary race and from health-care associations, all seeking to restrict it. They cite concerns that DTC ads could increase patient demand for higher cost drugs when less expensive alternatives may be available. DTC ads include magazine and newspaper ads that are distributed to the general public rather than to health-care providers, as well as ads broadcast through television or radio.

On Feb. 12, Rep. Rosa DeLauro (D-Conn.) introduced a bill (H.R. 4565), the Responsibility in Drug Advertising Act, that would place a three-year moratorium on DTC advertising of newly approved prescription drugs. The bill provides an exception to the moratorium through the possibility of a waiver, if the drug in question is a breakthrough drug with affirmative value to public health.

“The Responsibility in Drug Advertising Act is about protecting consumers from misinformation and advertising that promotes unnecessarily expensive prescription drugs,” DeLauro said. “At the end of the day, we should allow informed medical professionals, not advertising executives, to guide our healthcare spending. We must protect consumers from taking medications that may be unnecessary.”

DeLauro's bill has been referred to the House Energy and Commerce Committee for consideration. The House likely will not take action on the bill.

(Click image to enlarge.)

Democratic presidential candidate Hillary Clinton said in a fact sheet that, if elected, she would eliminate corporate write-offs for direct-to-consumer advertising, saving the government billions of dollars over the next decade. The fact sheet also said she would establish a mandatory Food and Drug Administration pre-clearance procedure for these ads funded through user fees paid by pharmaceutical manufacturers in order to be sure that the ads provide clear and understandable information to consumers.

Sen. Al Franken (D-Minn.)
March 3 introduced a bill (S. 2623) to end the tax deduction for prescription drug advertising. Franken said DTC advertisements “drive up demand for new and higher-cost prescriptions and treatments, which increases overall medical costs for American families and seniors.”

In 2014, spending on prescription drug advertisement reached $4.5 billion—a 30 percent increase from 2012, according to a press release on Franken's bill.

A group representing doctors has called for a halt to DTC ads. In November 2015, the American Medical Association adopted a policy that calls for a ban on DTC advertising of prescription drugs and medical devices, citing concerns that a growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives .

FDA's Oversight History

According to the FDA's website, no federal law has ever banned DTC advertising. Until the mid-1980s, drug companies gave information about prescription drugs only to doctors and pharmacists. However, during the 1980s, some drug manufacturers started to give the public more information on prescription drugs through DTC advertisements.

The FDA Office of Prescription Drug Promotion (OPDP) works to ensure that manufacturers provide information on their drug products that is truthful, balanced and accurately described. The OPDP oversees DTC drug ads by looking for and taking action against advertisements that violate the law, educating the industry and others about the specifics of the law, and encouraging better communication of promotional information provided to health-care professionals and consumers, the agency said.

The FDA said that “in most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used.”
The agency said it sees many ads at the same time the public sees them. Some companies voluntarily seek the agency's advice before releasing television advertisements, the agency said. If the FDA believes an advertisement violates the law, it can send a letter to the drug company asking that the ads be stopped.

Ads Spur Conversations

Some sources contacted by Bloomberg BNA pointed out that DTC prescription drug advertising can provide useful information to patients.

Asthika Goonewardene, a Bloomberg Intelligence analyst, told Bloomberg BNA Feb. 29, that DTC advertising helps patients learn about new drugs, and doctors don't always have the time to explain everything about a drug. The drug advertisements promote conversations between patients and health-care providers, he said.

Even though these ads promote new, more expensive drugs, there are protections in place to encourage the prescribing of lower cost alternatives, Goonewardene said.

“We're certainly seeing more activity in regard to those who want to restrict either the tax deduction or the ability to advertise prescription drugs to consumers,” Daniel L. Jaffe, executive vice president of government relations for the Association of National Advertisers (ANA), told Bloomberg BNA March 1.

“It's important for people to realize that large segments of the public do not have information about prescription drugs that would be important and useful to them,” Jaffe said.

“There have been studies that have shown that people are highly uninformed about depression, stroke, about diabetes” and “they do not go to a doctor,”
he added.

Jaffe said the ANA believes that “prescription drug advertising provides an enormous service to the public because it brings to their attention the potential way to deal with very serious threats to their life and their health.”

Regulation, Doctors'
Role

The FDA “has to agree to allow a drug to be on the market, and that's only allowed after very rigorous requirements,” Jaffe said. “Once it's on the market, then the advertising is very highly restricted. It's probably the most regulated area of advertising that I can think of where there are very clearly large mandated disclosures as to the benefits and the risks of the drugs.”

Jaffe also said that after patients view an ad, they can't just buy the product at a store or online. “You have to go to a learned intermediary, a doctor, and have them agree to the prescription,” he said.

“So even if something somehow slipped through the FDA's regulatory oversight and gave people a false impression of a drug, there's the doctor there to make the final determination,” Jaffe said.

For example, Jaffe said that when Viagra was first advertised, about a million people went to their doctors to talk about that product. After those discussions, more than 130,000 of them were found not to need the drug. However, their doctors found they had other conditions such as high blood pressure or diabetes, and they received treatment, he said.

“When you get people into a doctor's officer for any reason, it is often likely that you will find other conditions that have nothing to do with what got them in there in the first place,” Jaffe said.

Jaffe said there is a lot of information about drugs on the internet that is unregulated by the FDA and “there are false claims that are not being regulated by anybody,” Jaffe said. With prescription drug ads, “at least you are certain that the Food and Drug Administration has decided what data is allowed out onto the market, and if it's false or deceptive, the FDA will stop it.”

Holly Campbell, a spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), told Bloomberg BNA in a Feb. 29 e-mail that “research shows that accurate information about disease and treatment options makes patients and health-care providers better partners.”

“Providing FDA-regulated, scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer (DTC) advertising about prescription medicines,”
Campbell said. “Beyond increasing patient awareness of disease
(including undiagnosed conditions) and available treatments, DTC advertising has been found to increase awareness of the benefits and risks of new medicines and encourage appropriate use of medicines.”

Campbell also said DTC advertising “encourages patients to visit their health-care providers' offices for important conversations about health that might otherwise not take place.”

DTC advertising “is important because it helps patients have good conversations with their doctors,” John Kamp, consulting counsel to Wiley Rein LLP in Washington, told Bloomberg BNA Feb. 29. Kamp is executive director of the Coalition for Healthcare Communication, an industry group that promotes the free exchange of scientific and medical information.

“It's very important in that it enriches those conversations, the doctor-patient conversations, and leads to better outcomes,” Kamp said.

Industry Should Self-Regulate

On DeLauro's bill, Kamp said “it's nice that it has a waiver possibility because bad law ought to also be easily waived.”

“It's not surprising;
Congresswoman DeLauro has been a foe of the pharmaceutical industry for some time and it's pile-on time for the pharmaceutical industry,”
Kamp said. “The pharmaceutical industry isn't polling well these days, and those members of Congress have followed the poll to look for ways to look good to their constituents.”

Kamp said DeLauro's bill “would probably violate the First Amendment.”

“We never know for sure until the Supreme Court rules,” Kamp said. “But it's clearly a bill that's designed to punish the pharmaceutical industry, and in constitutional parlance, it's a speaker-based restriction and speaker-based restrictions seldom are found constitutional by the courts.”

“I think that PhRMA has done a very good job in its self-regulation guide that essentially says that in most cases there should be a delay in DTC advertising to make sure that health-care professionals know about a drug before there's discussion of it,” Kamp said. The guide also allows for immediate DTC “in cases where it might be appropriate.”

Kamp said there should be self-restraint and self-regulation regarding DTC ads and “self-regulation trumps government regulation virtually every time.”

Regarding the issue of drug costs, Kamp said “the doctor is the one who prescribes the drug and when generics are prescribeable and provide a reasonable alternative—that's what doctors, patients and insurance companies do.”

Kamp said consumers, doctors and insurance companies aren't “impotent in the face of direct-to-consumer advertising” and “the marketplace works pretty well and intelligent decision-making is what occurs.”

Ads Misleading, Increase Cost

Despite what some consider safeguards built into DTC advertising, some believe it is harmful and should be subject to stricter scrutiny.

Michael Carome, director of Public Citizen's Health Research Group, told Bloomberg BNA Feb. 29 that “over the years, we have always opposed direct-to-consumer advertising for many reasons. It's notable that the U.S. is only one of two countries, the other being New Zealand, that allows this type of direct-to-consumer advertising of prescription drugs.”

“There are several points why this is problematic. One is that the advertising that takes place really bears no relationship to public health needs,”
he said. “Generally, the drugs advertised are the newest brand name drugs and the full goal of the advertising is to increase drug company profits and not necessarily improve patient and public health.”

Carome also said the advertisements often are misleading. Sometimes an advertisement “misleads people to misunderstand the benefits that a drug might offer and downplays the risks” and “that can be dangerous,” he said.

“Ultimately the drug companies spend billions of dollars on this type of advertising and … that is a factor that drives up health-care costs generally and costs of prescription drugs in particular, because it becomes part of the company's budget,” he said. “Spending like this ultimately gets passed down to the people who pay for the products.”

Carome said DTC advertising prompts “patients to go to their doctor and ask for drugs that many times the patients don't need or there are better alternatives.”

“Armed with this information from the advertising, patients will sometimes pressure their doctors to prescribe things that really aren't the best for them,” he said. “And sometimes, perhaps too often, doctors will give in to that pressure rather than standing their ground.”

Carome said that given the current legal environment, he thinks it is unlikely that prescription drug DTC ads will be banned.

“They are pretty much, I think, here to stay,” he said. “The question is whether any reasonable limits could be placed on” prescription drug advertisements “that would pass legal muster and be able to resist challenges in court.”

Carome said any laws that would restrict DTC advertising would “no doubt” be challenged by drug companies.

“There have been, in our view, some rational proposals made, like not allowing prescription drug advertising for the first two or three years after a new drug comes on the market,” he said.

Important new safety information is often learned about new drugs in the first seven years after they come on the market, Carome said. “Perhaps there's some initial period of time that would be reasonable to place a limit”
on advertising “while we're learning important safety information about these drugs,” he said.

While drug companies would challenge limits on DTC advertising, “ultimately commercial speech is different than individual speech and is often subject to balancing tests where the free speech is balanced against other interests,”
he said. “And in this case there are important public health interests. So perhaps, depending upon the makeup of the court and who the judge is, it's possible that a case could be made that it is in the public health interest to limit that initial direct-to-consumer advertising soon after a new drug is approved and a good public health argument could be made to justify that.”

Does Advertising Increase Cost?

Howard Beales, professor of strategic management and public policy at The George Washington University School of Business, told Bloomberg BNA March 1 that “what people forget about the money spent on prescription drug advertising to consumers, is there's a whole lot more money spent on prescription drug advertising to doctors.”

“To at least some extent, it's a question of who is it more efficient to advertise to,”
he said. “If it's cheaper to advertise to consumers than it is to advertise to doctors, then there's no reason to think that it raises the cost of drugs or health care in general.”

Beales said “there is a lot of advertising that probably lowers cost. There's pretty good evidence for a variety of prescription drugs that direct-to-consumer advertising leads people to get treated who wouldn't otherwise.”

For instance, he said “the statin drugs [used for cholesterol control] is one place that's been pretty well studied, and it seems pretty clear that treatment has increased. Also, the antipsychotic drugs, depression treatments—same story—DTC advertising seems to have increased the number of people who get treated.”

“There isn't evidence that advertising in general raises cost or raises prices,” he said.

Beales said drug companies “are more likely to promote new drugs because those are the ones that people don't know about.”

“The question is, is there some equally effective but cheaper old drug, and normally that's not the case,” he said. “Normally, the newer drug is doing something better than the old drug and that's why it was worth the substantial [research and development] costs to develop it and bring it to the market in the first place.”

Newer drugs are “displacing something that doesn't work as well,” Beales said. The older drug is cheaper but “it doesn't do the job as well.”

Old, Bad Ideas

Jaffe said the proposals to ban advertising for a certain amount of time after a drug is approved and to take away the tax deduction “are not new ideas.”

In 2007, Sen. Edward M. Kennedy (D-Mass.) and Rep. Henry A. Waxman (D-Calif.) pushed a proposal to ban the advertising of prescription drugs for two to three years, which is very similar to DeLauro's bill, and “that was defeated,” Jaffe said. In 2010, Rep. Charles B. Rangel (D-N.Y.)
proposed to take away the tax deduction, and proposals like that also were “floated” in the Senate Finance Committee, and “that also was defeated,” Jaffe said.

“They are old ideas, and they are bad ideas,” Jaffe said.

“We're not saying that this should be an unregulated area,” Jaffe said. “Quite the contrary. We think that strong regulations for prescription drugs are essential. But, I believe that eliminating prescription drug ads would be found to be unconstitutional.”

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

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